22 results · 30ms · Sources: EU EUDAMED, US FDA

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MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526827837·***DISC*LEVAMED ANKLE SUPPORT BLACK I

MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES

FDA 510(k)
FDA Class 2 ·Cardiovascular

Zirlux

FDA UDI
HENRY SCHEIN, INC.·H65890105110·Zirlux Titanium Abutment 3 mmH compatible with:...

TiWAVE C Cervical Cage System

FDA UDI
Kalitec Direct LLC·B07320K0100110·Handle, Universal Slim with Depth Stops

PACK SHANNON BURRS LG20 MM STERILE DIA 2.0 X LENGTH 75 MM

FDA Adverse Event
Malfunction ·IN2BONES SAS·Product code GFF·February 3, 2026

O-LAS OPHTHALMIC PHOTODISRUPTOR

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NA

FDA UDI
STRYKER CORPORATION·07613153000426·4.0mm Round Solid Carbide Bur Medium

TiNano

FDA UDI
AURORA SPINE, INC.·B5211050105110·DISCOVERY Cervical Interbody Fusion System, 14m...

LYNX

FDA UDI
HNM TOTAL RECON LLC·00841742112138·LYNX Distal Humeral Locking Plate, Medial, Ti -...

NA

FDA UDI
STRYKER CORPORATION·04546540755063·10.5MM GRAFT SIZING GAUGE

BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

BE-VKMO 70000 #QUAD-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

BE-VEMO 7000 #QUADR-I HMO70000+VHK7100

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

QUATTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 14, 2013

UNKNOWN ZIMMER KNEE

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·March 1, 2011

GUGLIELMI DETACHABLE COILS (GDC)

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORP.·Product code HCG·February 11, 2008

ELITE 12CM ANGLED ATTACHMENT

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·October 28, 2020

Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

FDA Enforcement
Class II ·Completed·Accuray Incorporated·September 6, 2023